Cordis · 6 days ago
Lead Specialist Post-Market Surveillance (Remote)
United States
Full-time
Remote
Senior Level, Lead/Staff
8+ years expCordis is a global leader in cardiovascular and endovascular technology dedicated to saving lives. They are seeking a Lead Specialist in Post-Market Surveillance to collaborate with various internal and external stakeholders and manage the clinical evaluation process for medical devices, ensuring compliance with EU MDR requirements.
Health CareHealth DiagnosticsMedical
No H1B
U.S. Citizen Only
Responsibilities
Execute general medical writing, editing, and proofreading activities and systematic literature reviews for assigned CER projects
Develop CEPs, CERs, PMCF plans and evaluation reports, and SSCP reports in accordance to EU MDR requirements
Responsible for developing high quality surveys and executing them successfully
Perform periodic reviews of risk documentation, product labeling, and marketing claims as part of the clinical evaluation process
Be a key collaborator with the biostatistics and data management team for complete results interpretation and to ensure the delivery of accurate and relevant output
Represents the Clinical/Medical Affairs function and Clinical Evaluation Team on the EU-MDR Core Team(s), working closely with Core Team Leads on timelines and clinical needs
Ensure documents are produced in accordance with standard operating procedures, internal and external guidelines (e.g., MDD and MDR), and company templates
Communicates with stakeholders and obtains stakeholder alignment to ensure business objectives are met
Contributes to the strategic approach for the team’s clinical evaluations with consideration of the portfolio-level view of other strategic approaches and NB feedback
Assist in developing and implementing corporate procedures for medical and regulatory writing
Assist research and other project team members in additional responsibilities as required
Support Quality audits
Qualification
Required
Requires a minimum 8+ years of relevant experience with a Bachelor's degree; or equivalent education and experience; Or 6+ years and a Master's degree; Or a PhD with 3+ years experience; or equivalent experience
Where required, the role must hold an appropriate degree in the industry (eg. Legal)
Preferred
Minimum of 2 years of relevant medical writing experience
Direct experience authoring clinical evaluation documents, including: PMCF Plans, PMCF Reports, Clinical Evaluation Plans, Clinical Evaluation Reports, and Summary and Safety and Clinical Performance
Proficient knowledge of physiology and/or applicable disease states, medical terminology
Experience presenting scientific/clinical evidence in a written and oral manner to cross-functional teams
Familiarity with international regulatory requirements and knowledge of relevant standards (e.g. ISO 14155, ISO 14971, MedDev 2.7.1 rev 4, EU MDR, applicable MDCG)
Working knowledge of various writing style guidelines (e.g., AMA) and current publication practices and guidelines (ICMJE)
Experience planning and executing internet literature searches using databases such as PubMed, Embase
Working knowledge of biostatistics
Experience working with Quosa, Endnote or other literature repository and citation management tools
Demonstrated ability to build positive constructive relationships with cross-functional team members
Company
Cordis
Cordis Corporation, a Johnson & Johnson company, has pioneered less invasive treatments for vascular disease.
1001-5000 employees
Funding
Current Stage
Late StageTotal Funding
unknown2021-03-12Acquired
Leadership Team
Scott Drake
Chief Executive Officer
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